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The SpineFrontier® PedFuse® Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (Pseudarthrosis).

In addition, the SpineFrontier® Pedicle Screw System is indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (L3 to S1).

The SpineFrontier® PedFuse® Pedicle Screw System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine. The system consists of longitudinal rods, polyaxial screw assemblies, and cross connectors.

This document is a 510(k) summary for a medical device called the "PedFuse® Pedicle Screw System," specifically for the addition of a sliding washer component. It is a regulatory submission for substantial equivalence to previously cleared predicate devices.

It does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria in the manner typically associated with studies demonstrating AI or diagnostic device performance metrics (e.g., sensitivity, specificity, accuracy against a ground truth). This document primarily focuses on demonstrating that the new component (sliding washer) does not change the fundamental safety and effectiveness of the existing device and remains substantially equivalent to already cleared devices.

Therefore, most of the requested information cannot be extracted from this document as it pertains to a different type of regulatory submission and device.

However, I can extract information related to the device itself and its regulatory context:

• Device Name: PedFuse® Pedicle Screw System
• Manufacturer: SpineFrontier®
• Regulation Number: 21 CFR 888.3070
• Regulation Name: Pedicle screw spinal system
• Regulatory Class: Class II
• Product Code: MNH, MNI
• Indications for Use: The SpineFrontier® PedFuse® Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute instabilities or deformities of the thoracic, lumbar, and sacral spine, including degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (Pseudarthrosis). It is also indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (L3 to S1).
• Change from Previous System: Addition of a sliding washer.
• Material: Medical grade titanium alloy (ASTM F136).
• Predicate Devices: K133153, K123164, K092420 (SpineFrontier Pedfuse® Pedicle Screw System) and K071420 (Chameleon® FacetFuse® MIS Screw System as a reference).

Regarding your specific questions, based on the provided text, I can state the following:

1. Table of acceptance criteria and the reported device performance: Not applicable. This document is not about performance metrics like sensitivity or accuracy. It's about substantial equivalence for a hardware component.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. This document does not detail a test set for performance evaluation in the context of diagnostic or AI devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth establishment is not relevant for this type of hardware component submission.
4. Adjudication method: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a regulatory submission demonstrating substantial equivalence for a physical medical device component, not a study evaluating performance against specific acceptance criteria for a diagnostic or AI-driven device.

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The Facet FixxTM System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. For transfacet fixation, the screws are inserted through the inferior articular process across the facet joint and into the pedicle. For translaminar facet fixation, the screws are inserted through the lateral aspect of the spinous process, through the lamina, through the inferior articular process, across the facet joint and into the pedicle. The Facet Fixx System is intended for bilateral facet fixation, with or without bone graft, at single or multiple levels from C2 to S1 inclusive. The Facet Fixx System is indicated for treatment of any or all of the following: Degenerative disc disease (DDD) as defined by back pain of discogenic origins confirmed by history and radiographic studies, Degenerative disease of the facets with instability, Trauma (i.e. fracture or dislocation), Spondylolisthesis, Spondylolysis, Pseudoarthrosis and failed previous fusion which are symptomatic or which may cause secondary instability or deformity.

The Facet FixxTM System is a posterior facet spinal fixation system consisting of screws with and without washers. The cannulated screw is offered partially or fully threaded in various diameter and length combinations.

This device is a spinal fixation system, not an AI/ML device. Therefore, the questions related to AI/ML device performance and study design are not applicable. The provided text describes the device, its intended use, materials, and a comparison to predicate devices, focusing on mechanical performance.

Here's a breakdown of the relevant information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

• Test Set Sample Size: Not explicitly stated as a "test set" in the context of an algorithm. For mechanical testing, the number of samples tested for static/dynamic cantilever bending and axial pullout is not specified.
• Data Provenance: The mechanical testing was likely conducted in a laboratory setting, not with human patient data.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not applicable as this is a mechanical device, not an AI/ML diagnostic or prognostic system requiring expert-established ground truth.

4. Adjudication Method for the Test Set:

• Not applicable. Mechanical testing involves objective measurements rather than expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• Not applicable. This is not an AI/ML device.

6. Standalone Performance Study:

• Not applicable. This is not an AI/ML algorithm. The performance established is the mechanical performance of the device itself.

7. Type of Ground Truth Used:

• Mechanical Testing Results: The "ground truth" here is the objective measurement of the device's mechanical properties (static and dynamic cantilever bending, axial pullout strength) against established ASTM standards (F2193 and F543) and comparable predicate devices.

8. Sample Size for the Training Set:

• Not applicable. This is not an AI/ML device that uses a training set.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable.

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The VIPER® F2 Facet Fixation System is intended to stabilize the spine as an aid to fusion by the transfacet fixation method only:

Transfacet fixation: - The screws are inserted bilaterally through the superior side of the facet, across the facet joint and into the inferior pedicle.

This system is indicated for the posterior surgical treatment of any or all of the following at the L1 to S1 (inclusive) spinal levels: 1) Trauma, including spinal fractures and/or dislocations; 2) Spondylolisthesis; 3) Spondylolysis; 4) Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity; 5) Degenerative diseases which include: (a) degenerative disc disease (ddd) as defined by back pain of discogenic origin as confirmed by patient history with degeneration of the disc as confirmed by radiographic studies and/or (b) degenerative disease of the facets with instability.

The screws and washers that are the subject components of this submission are modified DISCOVERY® System screws and washers that are available in various geometries and sizes. Manufactured from ASTM F 136 implant grade titanium alloy.

The provided text describes the 510(k) summary for the VIPER® F2 Facet Fixation System. It focuses on demonstrating substantial equivalence to predicate devices through nonclinical mechanical testing, rather than device performance against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and a study proving their fulfillment cannot be extracted from this document in the typical sense of AI/medical device performance evaluation.

Here's an analysis based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics in the way a diagnostic AI device summary would. Instead, the "device performance" is demonstrated through nonclinical mechanical testing and comparison to predicate devices, implying that if the device performs comparably to legally marketed devices, it meets the unstated "acceptance criteria" for safety and effectiveness.

Nonclinical Test Summary and Implied Performance:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable as the study did not involve a test set of data points (e.g., medical images, patient records) for evaluation of the device's diagnostic or predictive performance. The "testing" involved mechanical benchmarks of the physical device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable. The device is an implantable medical device, not an AI or diagnostic tool requiring ground truth established by medical experts for performance evaluation. The "ground truth" for mechanical testing is established by engineering standards (ASTM F1798).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable. There was no clinical test set or human interpretation involved that would require an adjudication method.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

There was no MRMC comparative effectiveness study done. This device is a surgical implant, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. The device is a physical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the nonclinical mechanical testing was based on engineering standards (ASTM F1798) for evaluating spinal arthrodesis implants.

8. The sample size for the training set

This information is not applicable. There was no training set involved as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

This information is not applicable. There was no training set.

Summary of the Study:

The study proving the device meets acceptance criteria was a nonclinical mechanical testing program involving static and dynamic compression bending, and static and dynamic three-point bending, all conducted in accordance with ASTM F1798. The intent was to demonstrate that the modified components of the VIPER® F2 Facet Fixation System perform mechanically comparably to its predicate devices. No clinical tests were performed. The FDA's substantial equivalence determination was based on this nonclinical testing and comparison of intended use, design, materials, manufacturing methods, performance, sterility, biocompatibility, safety, and packaging design to legally marketed predicate devices.

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